MAUDE Adverse Event Report: MEDIVATORS INC DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR

Model Number DSD Edge 120V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

The customer is conducting an investigation as a follow-up to an "adverse reaction" that occurred to a patient post procedure.The user facility did not disclose the current patient status or if any medical treatment was administered.We understand the user facility is reviewing all their pre- and post-procedural standard operating procedures.The customer contacted steris asking we perform an evaluation of their equipment in an attempt to rule out the dsd edge aer as a contributor to the reported event.The user facility did not disclose the specific instruments that were used during the procedure subject of the reported event.A steris service technician inspected the aer and found no issues with the function or operation of the unit.The technician tested the unit, found it to be operating according to specifications and returned it to service.No additional issues have been reported.

Event Description

The user facility contacted steris, requesting functional testing of their dsd edge automated endoscope reprocessor.

• Brand Name: DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 14605 28th ave north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 16683984
• MDR Text Key: 312822265
• Report Number: 2150060-2023-00022
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DSD Edge 120V
• Device Catalogue Number: DSD3008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1